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DeepDx Prostate
EUDAMEDClass IVD General (EU MDR)
Ref DeepDx Prostsate-v1Model DeepDx Prostate-v1
by DeepBio MF
Identity
- Device Name
- DeepDx Prostate EUDAMED
- Model / Reference
- DeepDx Prostate-v1 EUDAMEDDeepDx Prostsate-v1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800064500032 EUDAMED
- Basic UDI-DI
- B-08800064500032 EUDAMED
- EMDN Code
- W02029092 VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Special Device Type
- -1202 EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
DeepDx Prostate by DeepBio MF — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08800064500032 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- DeepBio MF
- EUDAMED SRN
- KR-MF-000032476
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 924eae77-495c-42c2-8d63-4c69ddd37bc1 61 fields · synced Jun 18, 2026